AVANOS 47042Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770470429), received between Mar 17, 2023 and Jun 19, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 31, 2024Open, Classified

   The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

   Z-2422-2024 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Burst Container or Vessel

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00480 FOR THE FIRST EVENT. IT WAS REPORTED RECENTLY IR [INTERVENTIONAL RADIOLOGY] THE PATIENT'S BALLOON IS POPPING CAUSING HIM TO NEED FREQUENT EXCHANGES AND HOSPITAL ADMISSION FOR HIS HYPOGLYCEMIA. THERE WAS NO REPORTED INJURY.

  Patient problems: Hypoglycemia

  MAUDE report 25568572 ↗
• MalfunctionJun 19, 2026Burst Container or Vessel

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00486 FOR THE SECOND EVENT. IT WAS REPORTED RECENTLY IR [INTERVENTIONAL RADIOLOGY] THE PATIENT'S BALLOON IS POPPING CAUSING HIM TO NEED FREQUENT EXCHANGES AND HOSPITAL ADMISSION FOR HIS HYPOGLYCEMIA. THERE WAS NO REPORTED INJURY.

  Patient problems: Hypoglycemia

  MAUDE report 25568553 ↗
• MalfunctionMar 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED 28-APR-2023 STATED "IT WAS ALSO REPORTED THAT AN INEXPERIENCED DOCTOR MIGHT HAVE INJECTED NUTRITION INTO INFLATION PORT BY MISTAKE AND BALLOON BROKE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600114 ↗
• MalfunctionMar 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE GASTRIC-JEJUNAL TUBE WAS IN FOR A MONTH AND HAD BROKEN OFF JUST BELOW THE BALLOON. THE REST OF THE TUBE WAS IN THE JEJUNUM, WHICH HAD TO BE REMOVED VIA ENDOSCOPY. NO INJURY REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 7MAR2023, THE TUBE WAS PLACED ON (B)(6) 2022. THE TUBE IS USUALLY IN FOR SIX MONTHS WITH THIS PATIENT; HOWEVER, BROKE AFTER 3 MONTHS.

  Patient problems: Foreign Body In Patient

  MAUDE report 16564348 ↗